Open, multicenter, randomised, controlled phase IIIb study evaluating the immunogenicity and safety of subcutaneous versus intramuscular administration of GlaxoSmithKline Biologicals’ combined measles-mumps-rubella-varicella vaccine (MeMuRu-OKA) to healthy children aged 11 to 21 months. - MeMuRu-Oka-048
- Conditions
- Active immunization of healthy children aged 11 to 21 months against measles, mumps, rebella and varicella diseases
- Registration Number
- EUCTR2005-005944-22-DE
- Lead Sponsor
- GlaxoSmithKline GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.
•Birth weight > 2000g.
•Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, collection of blood samples) should be enrolled in the study.
•A male or female between 11 and 21 months of age at the time of the first vaccination if the investigator can assure that the subject will receive the second vaccination within an interval of 6 to 8 weeks and before the second birthday.
•Written informed consent obtained from the parent or guardian of the subject before any study procedure.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
•Previous vaccination against measles, mumps, rubella and/or varicella.
•History of previous measles, mumps, rubella and/or varicella/zoster diseases.
•Children from pregnant mothers who have a negative history of chickenpox.
•Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the present trial.
•Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisone, or equivalent, ? 0.5 mg/kg/day. Inhaled steroids are allowed).
•Chronical administration of salicylates
•Administration of a licensed vaccine not foreseen by the study protocol during the period starting from 30 days prior to study start and until study end (week 12)
•Children who have received immunoglobulins and/or any blood products within six months preceding the first dose or with planned administration of any of these products during the study period.
•Confirmed or suspected tuberculosis.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, or a family history of congenital or hereditary immunodeficiency.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including obvious allergic reactions to neomycin and/or egg proteins.
•Major congenital defects or serious chronic illness.
•History of any progressive neurologic disorders or seizures.
•Acute disease* at the time of enrolment.
•Residence in a household in which a person with high risk resides (e.g., newborns between 0-4 weeks old of mothers with negative history of chickenpox and without recorded vaccination against chickenpox, susceptible immunocompromised persons including those with HIV)
•Rectal temperature ? 38.0 °C (100.4 °F) at time of vaccination.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method